Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-28 @ 5:47 PM
Study NCT ID:
NCT01399320
Status:
COMPLETED
Last Update Posted:
2011-07-21
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ghnnam Excision Technique for Pilonidal Sinus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003487', 'term': 'Cyanoacrylates'}, {'id': 'D004659', 'term': 'Enbucrilate'}], 'ancestors': [{'id': 'D000179', 'term': 'Acrylates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D014014', 'term': 'Tissue Adhesives'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-20', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-20', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'healing of the sinus', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'recurrence', 'timeFrame': '1 year', 'description': 'no recurrence'}, {'measure': 'wound infection', 'timeFrame': '3-6 months', 'description': 'occurrence of wound sepsis'}, {'measure': 'patient satisfaction', 'timeFrame': '3 months', 'description': 'patient satisfied with the procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pilonidal disease', 'Excision', 'cyanoacrylate'], 'conditions': ['Pilonidal Sinus', 'Surgical Wound', 'Dressing by Cyanoacrylate']}, 'descriptionModule': {'briefSummary': 'Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity.here we try a minimmally invasive method for managing such condition', 'detailedDescription': 'Pilonidal disease is a common disorder of the sacrococcygeal region. It comprises a variety of problems, including infection/abscess and the development of a chronic sinus cavity. Incidence varies across countries and races .The cause remains controversial. Both congenital and acquired causes have been postulated Excision with a simple lay-open or performing marsupialization both result in a midline wound that takes several weeks to heal and there is a significant recurrence rate because of the open portal for hair insertion.so here we apply a new minimally invasive excision with cyanoacrylate dressing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient with pilonidal sinus\n\nExclusion Criteria:\n\n* pilonidal abscess or sever acute inflammation'}, 'identificationModule': {'nctId': 'NCT01399320', 'briefTitle': 'Ghnnam Excision Technique for Pilonidal Sinus', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Ghnnam Excision Technique for Pilonidal Sinus', 'orgStudyIdInfo': {'id': 'MansouraU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cyanoacrylate dressing,excesion', 'description': 'we excise the sinus tip then apply cyanoacrylate dressing and watch for healing', 'interventionNames': ['Procedure: cyanoacrylate']}], 'interventions': [{'name': 'cyanoacrylate', 'type': 'PROCEDURE', 'otherNames': ['histoacryl'], 'description': 'excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing', 'armGroupLabels': ['cyanoacrylate dressing,excesion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35665', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura Faculty of Medicine', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'wagih m ghnnam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'mansoura faculty of medicine general surgery department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wagih Mommtaz Ghnnam', 'oldOrganization': 'Mansoura faculty of medicine general surgery department'}}}}